智通财经APP讯，同源康医药-B(02410)公布，公司获浙江省药品监督管理局颁发的《药品生产许可 证》。本次获得药品生产许可证，预期将对公司扩大产能及拓展市场产生长远的积极作用，为后续开展 商业化生产奠定基础，有望早日为患者提供更好的治疗选择，以满足癌症治疗中亟待满足的医疗需求。 ...

注册地址：浙江省湖州市长兴县长兴经济开发区明珠路1278号长兴世贸大厦A座14层1403-2室 格隆汇1月23日丨同源康医药-B(02410.HK)宣布，公司获浙江省药品监督管理局颁发的《药品生产许可 证》。药品生产许可证详情如下： 企业名称：浙江同源康医药股份有限公司 有效期至：2031年1月22日 签发机关：浙江省药品监督管理局 本次获得药品生产许可证，预期将对公司扩大产能及拓展市场产生长远的积极作用，为后续开展商业化 生产奠定基础，有望早日为患者提供更好的治疗选择，以满足癌症治疗中亟待满足的医疗需求。 生产地址和生产范围：受托生产企业：凯莱英生命科学技术(天津)有限公司，天津开发区第七大街71 号，甲磺酸艾多替尼片*** 许可证编号：浙20260002 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410) 自願公告 本公司獲浙江省藥品監督管理局頒發《藥品生產許可證》 浙江同源康醫藥股份有限公司（「本公司」，連同其附屬公司統稱「本集團」）自願刊 發，以告知本公司股東及潛在投資者有關本集團最新業務發展的資料。 I. 藥品生產許可證主要信息 企業名稱：浙江同源康醫藥股份有限公司 註冊地址：浙江省湖州市長興縣長興經濟開發區明珠路1278號長興世貿大廈 A座14層1403-2室 生產地址和生產範圍：受託生產企業：凱萊英生命科學技術（天津）有限公 司，天津開發區第七大街71號，甲磺酸艾多替尼片*** 許可證編號：浙20260002 有效期至：2031年1月22日 簽發機關：浙江省藥品監督管理局 1 II. 對本公司的影響 本次獲得藥品生產許可證，預期將對本公司擴大產能及拓展市場產生長遠的 ...

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) has seen a stock price increase of over 4%, currently trading at 14.21 HKD with a transaction volume of 59.4 million HKD, following the announcement of its new drug's inclusion in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1 - The company is developing a first-class new drug, Tysun (TY-9591), which targets adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have specific EGFR mutations and CNS metastasis [1] - The NMPA's decision to include TY-9591 in the priority review list is a significant milestone for the company, potentially expediting the drug's approval process [1] - The intended indication for TY-9591 is for first-line treatment in patients with EGFR exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations [1]

Group 1 - The company, 同源康医药-B, announced that its investigational drug,甲磺酸艾多替尼片 (TY-9591), is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adult patients with specific EGFR mutations [3] - The board of directors noted unusual fluctuations in the company's stock price and trading volume but confirmed that, apart from the disclosed information, they are not aware of any reasons for these fluctuations or any material information that needs to be disclosed to avoid misleading the market [3] - As of the date of the announcement, the board confirmed that the company's business operations are stable and progressing smoothly, with no significant matters requiring disclosure that would raise concerns for the board or management [3]

Core Viewpoint - The company, ZhiYuanKang Pharmaceutical-B (02410), announced that its investigational drug, TY-9591 (Axitinib), is proposed to be included in the priority review list by the National Medical Products Administration (NMPA) for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1] Group 1 - The proposed indication for TY-9591 is for adult patients with NSCLC who have either exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, along with central nervous system (CNS) metastases [1] - The company's board has noted unusual fluctuations in the stock price and trading volume, but confirmed that they are not aware of any reasons for these fluctuations beyond what has been disclosed [1] - As of the date of the announcement, the board confirmed that the company's business operations are stable and progressing smoothly, with no significant matters requiring disclosure [1]

Core Viewpoint - The company Tongyuan Kang Pharmaceutical-B (02410.HK) announced that its investigational first-class new drug, Tyrosine Kinase Inhibitor (TY-9591), has been proposed for inclusion in the priority review list by the National Medical Products Administration (NMPA) [1] Group 1 - The proposed indication for TY-9591 is for first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletion (19DEL) or exon 21 (L858R) substitution mutations, along with central nervous system (CNS) metastases [1]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何意見，並明確表示概不就因本公告全部或任何部分內容而產生或因倚賴 該等內容而引致的任何損失承擔任何責任。 董事會亦已注意到本公司股份價格及成交量近期出現不尋常波動。經作出合理查 詢後，董事會確認，除上文所披露者外，截至本公告日期，其並不知悉導致有關 波動的任何原因，或為避免本公司證券出現虛假市場而須予披露的任何資料，或 根據香港法例第571章證券及期貨條例第XIVA部須予披露的任何內幕消息。 截至本公告日期，董事會確認本集團的業務經營正常穩定，其核心業務進展順 利，並無任何引起董事會和本公司管理層關注的須予披露的重大事項。 1 上市規則第18A.05條規定的警示聲明：無法保證本公司將能最終成功開發及銷售 相關產品。本公司股東及潛在投資者於買賣本公司股份時務請審慎行事。 TYK Medicines, Inc 浙江同源康醫藥股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2410） 自願公告 甲磺酸艾多替尼片（TY-9591片）擬納入優先審評；及 股價及成交量的不尋常變動 浙江同源康醫藥股份 ...

Core Viewpoint - Tongyuan Kang Pharmaceutical-B (02410) has seen a significant stock increase, rising over 10% and currently trading at 13.95 HKD with a transaction volume of 32.66 million HKD, following the announcement of its drug application for priority review [1] Group 1: Company Developments - On January 6, the CDE official website indicated that Tongyuan Kang Pharmaceutical's application for Tyrosine Kinase Inhibitor (TY-9591) is proposed for priority review [1] - The drug is intended for first-line treatment in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have epidermal growth factor receptor (EGFR) exon 19 deletions (19DEL) or exon 21 (L858R) substitution mutations, along with central nervous system (CNS) metastases [1] - The company previously garnered significant attention at the World Lung Cancer Conference in September, where it presented key Phase II clinical trial results for TY-9591 targeting brain metastases in non-small cell lung cancer [1]

消息面上，1 月 6 日，CDE 官网显示，同源康医药申报的甲磺酸艾多替尼片（TY-9591 片）拟纳入优先 审评，用于具有表皮生长因子受体（EGFR）外显子 19 缺失（19DEL）或外显子 21（L858R）置换突 变，并伴有中枢神经系统（CNS）转移的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者的一线 治疗。值得一提的是，在去年9月份的世界肺癌大会上，同源康医药发布的艾多替尼片针对非小细胞肺 癌脑转移关键Ⅱ期临床试验引起同行高度关注。 智通财经APP获悉，同源康医药-B(02410)涨超10%，截至发稿，涨7.97%，报13.95港元，成交额3266.34 万港元。 ...